DrugPatentWatch Database Preview
KYPROLIS Drug Profile
Email this page to a colleague
» See Plans and PricingWhen do Kyprolis patents expire, and when can generic versions of Kyprolis launch?
Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.
This drug has two hundred and nineteen patent family members in forty-one countries.
The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. Additional details are available on the carfilzomib profile page.
US ANDA Litigation and Generic Entry Outlook for Kyprolis
A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9th, 2019.
Summary for KYPROLIS
| International Patents: | 219 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 63 |
| Clinical Trials: | 65 |
| Patent Applications: | 224 |
| Drug Prices: | Drug price information for KYPROLIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KYPROLIS |
| DailyMed Link: | KYPROLIS at DailyMed |
Recent Clinical Trials for KYPROLIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen Research & Development, LLC | Phase 2 |
| Andrew Yee, MD | Phase 2 |
| Amgen | Phase 4 |
Paragraph IV (Patent) Challenges for KYPROLIS
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KYPROLIS | POWDER;INTRAVENOUS | carfilzomib | 202714 | 2018-11-28 |
| KYPROLIS | POWDER;INTRAVENOUS | carfilzomib | 202714 | 2017-10-05 |
| KYPROLIS | POWDER;INTRAVENOUS | carfilzomib | 202714 | 2016-07-20 |
US Patents and Regulatory Information for KYPROLIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-003 | Jun 7, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Onyx Therap | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-002 | Jun 3, 2016 | AP | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for KYPROLIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Austria | 496062 | Start Trial |
| Canada | 2865950 | Start Trial |
| Mexico | 2014010323 | Start Trial |
| Japan | 2014012676 | Start Trial |
| Brazil | PI0509879 | Start Trial |
| Canada | 2565407 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KYPROLIS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1781688 | 93015 | Luxembourg | Start Trial | PRODUCT NAME: CARFILZOMIB EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151123 |
| 1781688 | CR 2016 00014 | Denmark | Start Trial | PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123 |
| 1781688 | 122016000032 | Germany | Start Trial | PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119 |
| 1781688 | 2016/013 | Ireland | Start Trial | PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119 |
| 1781688 | 132016000047656 | Italy | Start Trial | PRODUCT NAME: CARFILZOMIB OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(KYPROLIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1060, 20151123 |
| 1781688 | PA2016010 | Lithuania | Start Trial | PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
